Recall Z-2824-2015— Medtronic Navigation, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2015-09-14, terminated 2015-12-03. It names one FDA 510(k) clearance: K050438. Product: P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.. Reason: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery..
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-14
- Terminated
- 2015-12-03
- Firm location
- Louisville, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
Reason for recall
Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.